Energy Expenditure & Activity During & After Exercise-Induced Weight Loss

July 6, 2021 updated by: University of Colorado, Denver
This project is aimed at determining whether an exercise-based weight loss intervention causes a compensation in some component of energy expenditure such that the increase in measured energy expenditure is less than the added exercise. The study will compare two separate exercise interventions to determine if this is influenced by exercise intensity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of this proposed study is to determine how total daily activity thermogenesis (TDAT) and total daily energy expenditure (TDEE) are regulated in obese humans attempting to lose weight and maintain weight loss through exercise. Two exercise interventions will be compared; a structured aerobic exercise program and a walking program. exercise activity thermogenesis (EAT) will be verified, and non-exercise physical activity (NEAT), total daily activity thermogenesis (TDAT), and TDEE will be measured using state-of-the-art technologies. Subjects will be studied during a 6 month intervention period and then during a 6 month follow-up period. It is hypothesized that the walking program will have more favorable effects on TDAT and TDEE during both the intervention and follow-up periods. If the investigators hypotheses are correct, then data from the proposed study could be used to improve the effectiveness of exercise-based weight loss and weight loss maintenance programs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Body mass index (BMI) 30-35.0 kg/m2
  • Age 18-45 years
  • Weight stable (<2 kg weight fluctuation during previous 6 months)
  • No regular exercise (> 1 bout of exercise/wk or participation in any sporting activities > 1 hr/wk)
  • No self-report of acute or chronic disease (diabetes, heart diseases, and joint problems in particular)
  • No current use of prescribed medications
  • No plans to relocate within the next year
  • No plans for extended travel (> 1 week) within the next 6 months
  • No tobacco use

For Females:

  • No evidence of amenorrhea (Regular menstrual cycles of 21-35 days)
  • Pre-menopausal status (self-report, to be confirmed during screening)
  • Pregnancy or lactating within the past year
  • No pregnancy or planned pregnancies; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control.

Exclusion Criteria:

  • Claustrphobia;
  • Any contraindication(s) to > MRI, e.g. aneurysm, cochlear implant, cardiac pacemaker, or implantable cardiac defibrillator, artificial heart valve, metallic stents, any implantable devices or shunt, weight less than 300 lbs;
  • Left Handed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1 Exercise
Subjects in the EX group will perform supervised exercise 5 d/wk. Exercise will consist primarily of walking on an inclined motor-driven treadmill, but alternate activities will be permitted for 20% of the total exercise sessions (1 of 5 days). Exercise sessions will be preceded by a 5 min warm-up performed at a HR corresponding to 40% of VO2max. The initial exercise duration and intensity at baseline will be 20 minutes at an intensity that elicits a heart rate (HR) corresponding to 60% of VO2max. The target EE will be achieved by a gradual progression of exercise duration and intensity over the first 8 weeks of the exercise program. The target exercise intensity will be the workload corresponding to 75% of VO2max.
Behavioral: Walking exercise
Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program. Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.
Experimental: 2 Walk
Subjects in the WALK group will also perform exercise 5 d/wk. Exercise will consist exclusively of walking on level grades, and will be prescribed in two equal duration bouts each day. Subjects in the WALK group will be individually prescribed a walking program based on the EE during moderate intensity walking. The target exercise intensity will be walking speeds corresponding 45% of VO2max.
Behavioral: Walking exercise
Subjects will be randomly assigned to either a structured, vigorous-intensity endurance exercise training program or an intermittent, low-intensity exercise program. Individualized exercise prescriptions will be designed to target an increase of 2500 kcal/wk, and the theoretical weight loss will be approximately 15 pounds (~6.8 kg) during the 6 month intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total daily energy expenditure, assessed using doubly labeled water
Time Frame: Prior to exercise intervention, and 6 months
Prior to exercise intervention, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total daily activity thermogenesis
Time Frame: Prior to exercise intervention, and 6 months
Prior to exercise intervention, and 6 months
Body weight and composition
Time Frame: Prior to exercise intervention, and 6 months
Prior to exercise intervention, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward Melanson, PhD, University of Colorado Division of Endocrinology, Metabolism, and Diabetes/Division of Geriatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07-0402
  • R01DK077088 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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